Early Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Patients With Liver Cirrhosis and Ascites: a Multicentre, Randomised Controlled Trial
The aim of this clinical trial is to compare the safety and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) implantation with standard treatment (diuretic medications, and if necessary, paracenteses) in patients with liver cirrhosis and development of ascites as the first decompensating event. By creating a shunt between the liver vein and the portal vein, blood is diverted from the portal vein directly into the hepatic vein, which results in a reduction of pressure in the portal vein so that development of ascites is reduced.
⁃ Patients eligible for inclusion in this trial must meet all of the following criteria:
• Patients ≥ 18 years and \< 80 years
• Liver cirrhosis as documented by previous liver biopsy or by a combination of typical clinical, biochemical and sonographic features
• Ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites
• INR ≤ 1.5
• Ability to understand the nature of the trial and the trial related procedures and to comply with them